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The Journal of Cardiovascular Surgery Feb 2022
Topics: Atherectomy; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Calcification
PubMed: 35179335
DOI: 10.23736/S0021-9509.21.12202-5 -
Cureus Oct 2020The coronary artery calcium score is considered the most useful marker for predicting coronary events. The high score reflects heavy calcification in the vessel, which... (Review)
Review
The coronary artery calcium score is considered the most useful marker for predicting coronary events. The high score reflects heavy calcification in the vessel, which is more challenging to treat with the percutaneous intervention (PCI). To prepare this type of heavily calcified lesion intravascular lithotripsy (IVL) technology can be used prior to PCI, which is based on the concept of converting electrical energy into mechanical energy. It harmlessly and selectively disrupts both the shallow and deep deposits of calcium. The balloon-based catheters of this system emit sonic waves that transfer to the adjacent tissue resulting in improvement in vessel compliance with the slightest soft tissue loss. Therefore, making the treatment of calcified lesions more feasible, effective, and also simplify complex lesions. The lesions considered for lithotripsy-enhanced balloon dilation include calcified coronary lesions and peripheral vasculature lesions. This article reviews the use of IVL in calcified coronary artery disease, its advantages, and disadvantages while comparing it with other techniques like high-pressure balloons and rotational atherectomy devices. A thorough search of databases like PubMed and Google Scholar was performed, which uncovered 35 peer review articles. Keywords utilized in the data search were calcified coronary artery disease, coronary lithotripsy, calcification, and calcified atherosclerotic plaque. According to rotational atherectomy and intravascular lithotripsy trials, the latter was safer, mainly by decreasing atheromatous embolization risk. Deciphering these studies, it seems like IVL is better at parameters like procedural and clinical success rate, acute lumen gain, and less residual stenosis except in-hospital major adverse cardiovascular events (MACE), which was better in rotational atherectomy (RA). However, when lesion crossings are present, the atherectomy technique is still considered as first-line therapy. In clinical practice, despite these encouraging data for treating calcified lesions, IVL is grossly underutilized because of substantial costs and perceived significant procedural risk effects on the cardiac rhythm like causing 'shock topics' and asynchronous cardiac pacing. More longer-term clinical data and extensive researches are required to validate its safety and efficiency.
PubMed: 33194488
DOI: 10.7759/cureus.10922 -
Journal of Vascular Surgery Mar 2022Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks...
OBJECTIVE
Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks including distal embolization and arterial perforation. This study aimed to examine the safety and effectiveness of a novel atherectomy system to treat femoropopliteal and below-knee peripheral arterial disease.
METHODS
The Revolution Peripheral Atherectomy System (Rex Medical LP, Conshohocken, Pa) was studied in 121 patients with 148 femoropopliteal and below-knee lesions, enrolled at 17 United States institutions. Technical success was defined when the post-atherectomy angiographic stenosis was ≤50%, as assessed by an independent core laboratory. Major adverse events were adjudicated by an independent Clinical Events Committee.
RESULTS
Among 148 site-identified target lesions in 121 patients, 21.4% were in the superficial femoral artery, 13.7% involved the popliteal artery, and 67.9% were in tibial arteries; 3.1% involved more than one segment. Technical success was 90.2%, with stenoses decreasing from 73% ± 19% at baseline to 42% ± 14% after atherectomy. Adjunctive treatment after atherectomy included angioplasty with uncoated balloons in 91%, drug-coated balloons in 11%, bare stent deployment in 8%, and drug-eluting stent placement in 3%. Procedural success (<30% residual stenosis) was achieved in 93.7% of target lesions. Complications during the procedure included one target vessel perforation and two distal embolizations; each of which were adjudicated by the Clinical Events Committee as unrelated to the device and were not visualized angiographically by the core laboratory. Freedom from major adverse events was 97.3% through 30 days. The Kaplan-Meier estimates of primary, assisted primary, and secondary patency were 81.6%, 87.7%, and 91.6% at 6 months, respectively.
CONCLUSIONS
The use of the Revolution Peripheral Atherectomy System was associated with few procedural complications and a high rate of success at the index procedure and through 6 months.
Topics: Aged; Aged, 80 and over; Angiography; Atherectomy; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Tibial Arteries; Time Factors; Treatment Outcome; United States; Vascular Patency
PubMed: 34624496
DOI: 10.1016/j.jvs.2021.08.107 -
EuroIntervention : Journal of EuroPCR... Apr 2023The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. ...
BACKGROUND
The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice. Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes. Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01).
CONCLUSIONS
The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.
Topics: Humans; Female; Aged; United States; Aged, 80 and over; Male; Treatment Outcome; Risk Factors; Medicare; Atherectomy; Femoral Artery; Peripheral Arterial Disease; Retrospective Studies; Endovascular Procedures
PubMed: 36373386
DOI: 10.4244/EIJ-D-22-00609 -
Vascular Health and Risk Management 2023The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream +... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.
METHODS
There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.
RESULTS
Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.
CONCLUSION
JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.
CLINICAL TRIAL REGISTRATION
NCT03206762.
Topics: Humans; Popliteal Artery; Paclitaxel; Angioplasty, Balloon; Prospective Studies; Carcinoma, Renal Cell; Treatment Outcome; Peripheral Arterial Disease; Time Factors; Neoplasm Recurrence, Local; Femoral Artery; Atherectomy; Kidney Neoplasms; Vascular Patency
PubMed: 36936551
DOI: 10.2147/VHRM.S403177 -
JACC. Cardiovascular Interventions Sep 2021
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Angiography; Humans; Treatment Outcome
PubMed: 34503749
DOI: 10.1016/j.jcin.2021.07.017 -
Journal of the American Heart... Sep 2019Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex... (Comparative Study)
Comparative Study Observational Study
Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/without PTA). We explored sex differences in treatment modality by arterial segment (iliac, femoropopliteal, and tibial) with multivariable logistic regression. We used Kaplan-Meier survival analysis and multivariable Cox regression to study sex differences in arterial reintervention and occlusion. In this cohort, patients (n=58 247, mean age 68 years, 41% women,) had 106 073 arteries treated (median=2 arteries, interquartile range=1-3). Half (50%) of these arteries were treated with stents, 39% with PTA alone, and 11% with atherectomy. After risk adjustment, women were less likely to undergo stenting or atherectomy (versus PTA alone) in the femoropopliteal (stent risk ratio=0.78 [0.74-0.82]; atherectomy risk ratio=0.69 [0.58-0.82]) and tibial arteries (stent risk ratio=0.70 [0.55-0.89]; atherectomy risk ratio=0.87 [0.70-1.07]). In the iliac arteries there was no sex difference in stenting, and atherectomy was rarely used (0.2%). Women underwent reintervention in the femoropopliteal arteries (hazard ratio=1.28 [1.17-1.40]) or developed an occlusion in the iliac (hazard ratio=1.42 [1.12-1.81]) and femoropopliteal arteries (hazard ratio=1.19 [1.06-1.34]) more frequently than men. Conclusions Women were less likely to undergo stenting or atherectomy and had higher rates of occlusion and reintervention, especially in the femoropopliteal arteries. Evidence-based guidelines are needed to guide optimal use of endovascular treatments for men and women.
Topics: Aged; Aged, 80 and over; Angioplasty; Atherectomy; Databases, Factual; Female; Healthcare Disparities; Humans; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Risk Assessment; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome
PubMed: 31475624
DOI: 10.1161/JAHA.119.013088 -
Gefasschirurgie : Zeitschrift Fur... 2021The cooperation of physicians, engineers and other sciences results in a steady launching of effective tools for vascular treatment, which further support the... (Review)
Review
The cooperation of physicians, engineers and other sciences results in a steady launching of effective tools for vascular treatment, which further support the dominating position of endovascular therapy in the field of PAD. Parallel to the treatment options, non-radiation based image guidance is another area, where innovation helps to reduce radiation burden for patient and staff members without losing procedural quality and despite a growing number of radiation based procedures. Meanwhile, the available portfolio of endovascular tools allows to treat every vessel segment with results comparable to or even better then open surgery. This survey presents new techniques, tools and recently published results from related trials, which will probably have further influence on PAD treatment in the coming years.
PubMed: 34404965
DOI: 10.1007/s00772-021-00802-z -
Circulation Journal : Official Journal... May 2021The aim of the study was to assess anatomical and procedural predictors of clinical and procedural failure of rotational atherectomy (RA) in an all-comers... (Observational Study)
Observational Study
BACKGROUND
The aim of the study was to assess anatomical and procedural predictors of clinical and procedural failure of rotational atherectomy (RA) in an all-comers population.Methods and Results:A total of 534 consecutive patients who underwent RA were included in a double-center observational study. The primary composite endpoint consisted of: rota-wire introduction failure, burr-passage failure, periprocedural complications and procedure-related major adverse events. The second primary endpoint included rota-wire introduction failure and burr-passage failure. The primary endpoint occurred in 76 (14.2%) patients and the second primary endpoint occurred in 64 (12%) Periprocedural complications occurred in 23 (4.3%) and procedure-related adverse events in 23 (4.3%) patients. Multivariable analysis revealed angulation on lesion ≤90° (HR=2.18, 95% CI: 1.21-3.94, P=0.0096) and sequential lesion (HR=1.89, 95% CI: 1.01-3.54, P=0.046) as independent predictors of no clinical success of RA. Multivariable analysis revealed again that angulation on lesion ≤90° (HR=2.26, 95% CI: 1.16-4.40, P=0.02) and sequential lesion (HR=3.77, 95% CI: 1.64-8.69, P<0.01) as independent predictors of no procedural success of RA.
CONCLUSIONS
The presence of an acute angulation on lesion and sequential lesion are independent determinants of clinical and procedural failure of RA. Further research is necessary to establish a score predicting RA failure, which can help in preproceduralrisk stratification of patients undergoing complex percutaneous coronary intervention with RA.
Topics: Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Treatment Outcome; Vascular Calcification
PubMed: 33883385
DOI: 10.1253/circj.CJ-20-1222 -
Journal of Vascular Surgery Jan 2023We evaluated limb salvage (LS), amputation-free survival (AFS), and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and...
OBJECTIVE
We evaluated limb salvage (LS), amputation-free survival (AFS), and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and atherectomy for treatment of infrapopliteal disease (IPD) with chronic limb-threatening ischemia (CLTI).
METHODS
All index peripheral vascular interventions for IPD and CLTI were identified from the Vascular Quality Initiative registry. Of the multilevel procedures, the peripheral vascular intervention type was indexed to the infrapopliteal segment. Propensity score matching was used to control for baseline differences between groups. Kaplan-Meier and Cox regression were used to calculate and compare LS and AFS.
RESULTS
The 3-year LS for stenting vs POBA was 87.6% vs 81.9% (P = .006) but was not significant on Cox regression analysis (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.56-0.76; P = .08). AFS was superior for stenting vs POBA (78.1% vs 69.5%; P = .001; HR, 0.73; 95% CI, 0.60-0.90; P = .003). LS was similar for POBA and atherectomy (81.9% vs 84.8%; P = .11) and for stenting and atherectomy (87.6% vs 84.8%; P = .23). The LS rate after propensity score matching for POBA vs stenting was 83.4% vs 88.2% (P = .07; HR, 0.71; 95% CI, 0.50-1.017; P = .062). The AFS rate for stenting vs POBA was 78.8% vs 69.4% (P = .005; HR, 0.69; 95% CI, 0.54-0.89; P = .005). No significant differences were found between stenting and atherectomy (P = .21 for atherectomy; and P = .34 for POBA). The need for TER did not differ across the groups but the interval to TER was significantly longer for stenting than for POBA or atherectomy (stenting vs POBA, 12.8 months vs 7.7 months; P = .001; stenting vs atherectomy, 13.5 months vs 6.8 months; P < .001).
CONCLUSIONS
Stenting and atherectomy had comparable LS and AFS for patients with IPD and CLTI. However, stenting conferred significant benefits for AFS compared with POBA but atherectomy did not. Furthermore, the interval to TER was nearly double for stenting compared with POBA or atherectomy. These factors should be considered when determining the treatment strategy for this challenging anatomic segment.
Topics: Humans; Chronic Limb-Threatening Ischemia; Ischemia; Risk Factors; Peripheral Arterial Disease; Treatment Outcome; Angioplasty, Balloon; Atherectomy; Limb Salvage; Chronic Disease
PubMed: 36031169
DOI: 10.1016/j.jvs.2022.08.020